UMIN-CTR Clinical Trial

Basic information
Public title	The clinical trial of blood kinetics upon the ingestion of fat-soluble foods.
Acronym	The clinical trial of blood kinetics upon the ingestion of fat-soluble foods.
Scientific Title	The clinical trial of blood kinetics upon the ingestion of fat-soluble foods. -A Randomized Double-blind Placebo-controlled Crossover trial-
Scientific Title:Acronym	The clinical trial of blood kinetics upon the ingestion of fat-soluble foods. -A Randomized Double-blind Placebo-controlled Crossover trial-
Region	Japan

Condition
Condition	None(Healthy subjects)
Classification by specialty	Not applicable Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate blood kinetics of lycopene upon ingestion of foods containing processed tomato extract and to confirm the absorption of lycopene to the serum by a double-blind, placebo-controlled crossover trial.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Comparison of the serum lycopene concentration at each sampling point and of AUC 0-36h of lycopene between intake of processed tomato extract and normal tomato extract(The analysis of actual measured values and variation from baseline after the loading tomato extracts).
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Cross-over
Randomization	Randomized
Randomization unit	Individual
Blinding	Double blind -all involved are blinded
Control	Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Prevention
Type of intervention	Food
Interventions/Control_1	A single ingestion of the natural extract - washout period(6 days or more)- single ingestion of the processed extract
Interventions/Control_2	A single ingestion of the processed extract - washout period(6 days or more)- single ingestion of the natural extract
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	65 years-old >
Gender	Male and Female
Key inclusion criteria	1) Japanese males and females from 20 to 64 years old when the consent is obtained 2) Subjects with the normal fasting serum triglyceride, HDL-cholesterol and LDL-cholesterol values at the screening test. 3) Subjects available at every designated visit. 4) Subjects who agree to participate in this study and can put a signature and date to informed consent form by themselves prior to the study.
Key exclusion criteria	(1) Subjects with hepatic, renal, cardiac or organ disorders or diabetes or other serious diseases. (2) Subjects with a surgical history of the digestive system (except appendicectomy). (3) Subjects with a history of a drug or food allergy. (4) Subjects currently under treatment with chronic diseases. (5) Subjects who are pregnant or intend to become pregnant during the study or are lactating. (6) Subjects who cannot restrict the intake of foods that may influence the measurement of the samples during the study. (7) Subjects who take excessive alcohol (equivalent to 60 g pure ethanol/day in average consumption). (8) Subjects who participate in other clinical trials. (9) Subjects who have a history of feeling ill or unwell during or after the blood draw. (10) Subjects who have donated over 400 mL of blood within the last three months prior to the screening of this study or expect to donate the same during the study. (11) Subjects with extremely irregular diet (night-shift worker, etc). (12) Subjects who have smoked within 6 months. (13) Subjects who need to avoid taking the foods that do not clearly indicate the origin of all ingredients, because of religions, etc. (14) Subjects judged as unsuitable for this study by the investigator for other reasons.
Target sample size	30

Research contact person
Name of lead principal investigator	1st name Kazuhiko Middle name Last name Takano
Organization	Medical Corporation Hokubukai Utsukushigaoka Hospital
Division name	Clinical Pharmacology Center
Zip code	004-0839
Address	61-1, Sinei, Kiyota-ku, Sapporo, Hokkaido, Japan
TEL	011-882-0111
Email	takano@ughp-cpc.jp

Public contact
Name of contact person	1st name Yoshiyuki Middle name Last name Shirakura
Organization	FUJIFILM Healthcare Laboratory Co., Ltd.
Division name	Department of Supplement product management
Zip code	206-0024
Address	6F Kenkyu Bld., 2-5-1, Suwa, Tama-shi, Tokyo
TEL	042-339-8926
Homepage URL
Email	yoshiyuki.shirakura@fujifilm.com

Sponsor
Institute	Medical Corporation Hokubukai Utsukushigaoka Hospital
Institute
Department

Funding Source
Organization	FUJIFILM Healthcare Laboratory Co., Ltd
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Institutional Review Board of Medical Corporation Hokubukai Utsukushigaoka Hospital
Address	61-1, Sinei, Kiyota-ku, Sapporo, Hokkaido, Japan
Tel	011-881-0111
Email	Matsuda@ughp-cpc.jp

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions	医療法人北武会　美しが丘病院 （北海道） (Medical Corporation Hokubukai Utsukushigaoka Hospital (Hokkaido))

Other administrative information
Date of disclosure of the study information	2020 Year 12 Month 31 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2019 Year 11 Month 18 Day
Date of IRB
Anticipated trial start date	2020 Year 02 Month 18 Day
Last follow-up date	2020 Year 04 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2020 Year 02 Month 17 Day
Last modified on	2020 Year 02 Month 17 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045047